| CTRI Number |
CTRI/2026/01/102244 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CBCT Study to Compare Two Different Tools Used for Apical Plug Formation in Immature Permanent Teeth |
|
Scientific Title of Study
|
Comparative evaluation of two different tools for creating an apical plug in immature permanent teeth- a CBCT study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Bagade |
| Designation |
Pg Trainee |
| Affiliation |
SCB dental college and hospital, Cuttack |
| Address |
Department of Pediatric and Preventive Dentistry,
SCB dental college and hospital, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9987152574 |
| Fax |
|
| Email |
bagadeshweta2574@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prayas Ray |
| Designation |
Associate Professor |
| Affiliation |
SCB dental college and hospital, Cuttack |
| Address |
Department of Pediatric and Preventive Dentistry,
SCB dental college and hospital, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9861421455 |
| Fax |
|
| Email |
askdrprayas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Bagade |
| Designation |
PG Trainee |
| Affiliation |
SCB dental college and hospital, Cuttack |
| Address |
Department of Pediatric and Preventive Dentistry,
SCB dental college and hospital, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9987152574 |
| Fax |
|
| Email |
bagadeshweta2574@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB Dental College and Hospital,
Manglabag, Professors Colony, Cuttack, Odisha 753007
|
|
|
Primary Sponsor
|
| Name |
Shweta Bagade |
| Address |
Department of Pediatric and Preventive Dentistry,
SCB dental college and hospital, Cuttack |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Bagade |
SCB Dental College and Hospital, Cuttack |
PG Department of Pediatric and Preventive Dentistry
Cuttack
ORISSA |
9987152574
bagadeshweta2574@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SCB DENTAL COLLEGE AND HOSPITAL, CUTTACK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, (2) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MTA apical plug using e-MTA carrier |
MTA apical plug (3–5 mm) was placed in a single visit using a e-MTA carrier under rubber dam isolation. The thickness and position of the apical plug were confirmed radiographically. Obturation was completed after 24 hours following confirmation of MTA set. Patients were subsequently followed up clinically at 1, 6, and 12 months to evaluate treatment outcomes. |
| Intervention |
MTA apical plug using spinal needle |
MTA apical plug (3–5 mm) was placed in a single visit using a sterile spinal needle under rubber dam isolation. The thickness and position of the apical plug were confirmed radiographically. Obturation was completed after 24 hours following confirmation of MTA set. Patients were subsequently followed up clinically at 1, 6, and 12 months to evaluate treatment outcomes. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1.Teeth with Cveks criteria score 3 and 4
2.Children exhibiting Ellis class IV anterior tooth fracture
3.Traumatically involved young maxillary central incisors
4.Teeth having sufficient crown structure for full coverage or semi-permanent restorations
5.Periapical index score less than 3 will be included in the study |
|
| ExclusionCriteria |
| Details |
1.Teeth with more than two third root resorption radiographically
2.Children with systemic disorder
3.Teeth with root caries
4.Teeth with excessive mobility
5.Teeth with root fracture
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time taken for apical plug formation in seconds
2.Presence or absence of voids.
3.Thickness of apical plug
4.Extrusion of material beyond apex
5.Root fractures
|
CBCT evaluation of apical plug will be done during the same visit
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Tenderness on percussion.
3. Presence or absence of sinus / fistula.
1. Pain
2. Tenderness on percussion.
3. Presence or absence of sinus / fistula.
|
The following parameters are evaluated during 1 , 6, 12 month follow up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled study will be carried out in SCB Dental College and Hospital Cuttack, Odisha to compare the efficacy of an e-MTA carrier and a spinal needle for MTA apical plug placement in immature permanent teeth. Eligible children with traumatically involved immature maxillary central incisors will be randomly allocated into two study groups based on the tool used. Parameters evaluated include time taken for apical plug formation during the procedure, CBCT-based assessment of apical plug thickness, voids, material extrusion after apical plug formation and root fractures. Clinical evaluation will be done to assess treatment outcome during the follow-up period. |